Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 26492-26494 [2017-11818]
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26492
Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Notices
reports annually from 200 to 1,200
mandatory and voluntary users of the
electronic reporting system. We utilized
the upper-bound estimate of 1,200 for
these calculations.
We estimate that notifying the
immediate previous source(s) will take
0.6 hours per reportable food and
notifying the immediate subsequent
recipient(s) will take 0.6 hours per
reportable food. We also estimate that it
will take 0.6 hours for the immediate
previous source and/or the immediate
subsequent recipient to also notify their
burden will not affect voluntary
reporters of reportable food events.
Therefore, we estimate that the total
burden of notifying the immediate
previous source(s) and immediate
subsequent recipient(s) under section
417(d)(6)(B)(i) and (ii), (d)(7)(C)(i) and
(ii) of the FD&C Act for 1,200 reportable
foods will be 2,880 hours annually
(1,200 × 0.6 hours) + (1,200 × 0.6 hours)
+ (1,200 × 0.6 hours) + (1,200 × 0.6
hours). This annual burden is shown in
table 1.
immediate previous source(s) and/or
immediate subsequent recipient(s). The
Agency bases its estimate on its
experience with mandatory and
voluntary reports submitted to FDA.
Although it is not mandatory under
FDAAA, section 1005 that responsible
persons notify the sources and
recipients of instances of reportable
food, for purposes of the burden
estimate we are assuming FDA would
exercise its authority and require such
notifications in all such instances for
mandatory reporters. This notification
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity/Section
Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total hours
Maintenance of reportable food records under
section 417(g) of the FD&C Act—mandatory
reports.
Maintenance of reportable food records under
section 417(g) of the FD&C Act—voluntary reports.
1,200
1
1,200
0.25 (15 minutes) .........
300
4
1
4
0.25 (15 minutes) .........
1
Total ...............................................................
........................
........................
........................
.......................................
301
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1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Recordkeeping: As noted previously,
section 417(g) of the FD&C Act requires
that responsible persons maintain
records related to reportable foods
reports and notifications under section
417 of the FD&C Act for a period of 2
years. Based on past FDA experiences,
we estimate that each mandatory report
and its associated notifications will
require 30 minutes of recordkeeping for
the 2-year period, or 15 minutes per
record per year. The annual
recordkeeping burden for mandatory
reportable food reports and their
associated notifications is thus
estimated to be 300 hours (1,200 × 0.25
hours).
We do not expect that records will
always be kept in relation to voluntary
reportable food reports. Therefore, we
estimate that records will be kept for
four voluntary reports we expect to
receive annually. The recordkeeping
burden associated with voluntary
reports is thus estimated to be 1 hour
annually (4 × 0.25 hours). The estimated
total annual recordkeeping burden will
be 301 hours annually (1,200 × 0.25
hours) + (4 × 0.25 hours). This annual
burden is shown in table 2.
Dated: June 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–11821 Filed 6–6–17; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–2734]
Oncologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency)
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. FDA is establishing a docket for
public comment on this document.
DATES: The public meeting will be held
on July 12, 2017, from 8 a.m. to 5 p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Building
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/
SUMMARY:
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2017–N–2734.
The docket will close on July 10, 2017.
Submit either electronic or written
comments on this public meeting by
July 10, 2017. Late, untimely filed
comments will not be considered.
Electronic comments must be submitted
on or before July 10, 2017. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight eastern time, July 10, 2017.
Comments received by mail/hand
delivery/courier for written/paper
submissions will be considered timely if
they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Comments received on or before June
26, 2017, will be provided to the
committee. Comments received after
that date will be taken into
consideration by the Agency.
You may submit comments as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to
E:\FR\FM\07JNN1.SGM
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Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
https://www.regulations.gov will be
posted to the docket unchanged.
Because your comment will be made
public, you are solely responsible for
ensuring that your comment does not
include any confidential information
that you or a third party may not wish
to be posted, such as medical
information, your or anyone else’s
Social Security number, or confidential
business information, such as a
manufacturing process. Please note that
if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–2734 for ‘‘Oncologic Drugs
Advisory Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
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20:16 Jun 06, 2017
Jkt 241001
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Jennifer Shepherd, 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:
ODAC@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.
SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss
biologics license application (BLA)
125646, for tisagenlecleucel-T
suspension for intravenous use. The
application was submitted by Novartis
Pharmaceuticals Corp. The proposed
indication (use) for this product is for
the treatment of pediatric and young
adult patients 3 to 25 years of age with
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
26493
relapsed/refractory B-cell acute
lymphoblastic leukemia (ALL).
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. All electronic and
written submissions submitted to the
Docket (see the ADDRESSES section) on
or before June 26, 2017, will be
provided to the committee. Oral
presentations from the public will be
scheduled between approximately 10:30
a.m. to 11 a.m. and 3:30 p.m. to 4 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 June 16, 2017. 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 June 19, 2017.
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
Jennifer Shepherd 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
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Federal Register / Vol. 82, No. 108 / Wednesday, June 7, 2017 / Notices
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: June 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–11818 Filed 6–6–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–2094]
Developing Rabies Monoclonal
Antibody Products as a Component of
Rabies Post-Exposure Prophylaxis;
Public Workshop; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a public workshop
regarding development of rabies
monoclonal antibody products to be
used in conjunction with licensed rabies
vaccine as part of a rabies post-exposure
prophylaxis (PEP) regimen. This public
workshop is intended to provide
information for, and gain perspective
from, health care providers, other U.S.
Government Agencies, academic
experts, industry, and other
stakeholders on various aspects of
development efforts pertaining to
animal models, laboratory assays, and
clinical trials.
DATES: The public workshop will be
held on July 17, 2017, from 8:30 a.m. to
5 p.m. Submit either electronic or
written comments on this public
workshop on or before July 31, 2017.
See the SUPPLEMENTARY INFORMATION
section for registration date and
information. The workshop draft
Agenda will be made available at:
https://www.fda.gov/Drugs/NewsEvents/
ucm540832.htm prior to the meeting.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Entrance for the public workshop
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
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Jkt 241001
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows. Please note that late, untimely
filed comments will not be considered.
Electronic comments must be submitted
on or before July 31, 2017. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of July
31, 2017. Comments received by mail/
hand delivery/courier (for written paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
Instructions: All submissions received
must include the Docket No. FDA–
2017–N–2094 for ‘‘Developing Rabies
Monoclonal Antibody Products as a
Component of Rabies Post-Exposure
Prophylaxis.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read the electronic and written/paper
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lori
Benner and/or Jessica Barnes, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6221,
Silver Spring, MD 20993–0002, 301–
796–1300.
E:\FR\FM\07JNN1.SGM
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Agencies
[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)]
[Notices]
[Pages 26492-26494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-11818]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-2734]
Oncologic Drugs Advisory Committee; Notice of Meeting;
Establishment of a Public Docket; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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. FDA is establishing a docket
for public comment on this document.
DATES: The public meeting will be held on July 12, 2017, from 8 a.m. to
5 p.m.
ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 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.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2017-N-2734. The docket will close on July 10,
2017. Submit either electronic or written comments on this public
meeting by July 10, 2017. Late, untimely filed comments will not be
considered. Electronic comments must be submitted on or before July 10,
2017. The https://www.regulations.gov electronic filing system will
accept comments until midnight eastern time, July 10, 2017. Comments
received by mail/hand delivery/courier for written/paper submissions
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Comments received on or before June 26, 2017, will be provided to
the committee. Comments received after that date will be taken into
consideration by the Agency.
You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to
[[Page 26493]]
https://www.regulations.gov will be posted to the docket unchanged.
Because your comment will be made public, you are solely responsible
for ensuring that your comment does not include any confidential
information that you or a third party may not wish to be posted, such
as medical information, your or anyone else's Social Security number,
or confidential business information, such as a manufacturing process.
Please note that if you include your name, contact information, or
other information that identifies you in the body of your comments,
that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2017-N-2734 for ``Oncologic Drugs Advisory Committee; Notice of
Meeting; Establishment of a Public Docket; Request for Comments.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jennifer Shepherd, 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: ODAC@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.
SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss biologics license application
(BLA) 125646, for tisagenlecleucel-T suspension for intravenous use.
The application was submitted by Novartis Pharmaceuticals Corp. The
proposed indication (use) for this product is for the treatment of
pediatric and young adult patients 3 to 25 years of age with relapsed/
refractory B-cell acute lymphoblastic leukemia (ALL).
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.
All electronic and written submissions submitted to the Docket (see the
ADDRESSES section) on or before June 26, 2017, will be provided to the
committee. Oral presentations from the public will be scheduled between
approximately 10:30 a.m. to 11 a.m. and 3:30 p.m. to 4 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 June
16, 2017. 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 June 19, 2017.
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 Jennifer Shepherd 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
[[Page 26494]]
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: June 1, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11818 Filed 6-6-17; 8:45 am]
BILLING CODE 4164-01-P