Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 13823-13824 [2017-05188]
Download as PDF
Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices
13823
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Absenteeism guidance
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Notify FDA of Plan Activation and Deactivation ............................................
2
1
2
16
32
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Absenteeism guidance
Number of
recordkeepers
Number of records
per recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours
Develop Initial Plan ................................
70
1
70
500
35,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05100 Filed 3–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1063]
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) 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 meeting will be held on
March 29, 2017, from 8 a.m. to 5 p.m.
Submit either electronic or written
comments on this document by March
28, 2017. Late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
before March 28, 2017. The https://
www.regulations.gov electronic filing
system will accept comments until
midnight Eastern Time at the end of
March 28, 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.
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
SUMMARY:
VerDate Sep<11>2014
18:19 Mar 14, 2017
Jkt 241001
Sheraton College Park North
Hotel, Chesapeake Ballroom, 4095
Powder Mill Road, Beltsville, MD
20705. The hotel’s telephone number is
301–937–4422. 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.
You may submit comments as
follows:
ADDRESSES:
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’’).
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
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–1063 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 DATES), 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
E:\FR\FM\15MRN1.SGM
15MRN1
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
13824
Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices
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:
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:
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: During the morning session
of March 29, 2017, the committee will
discuss biologics license application
(BLA) 761064, rituximab/hyaluronidase
injection for subcutaneous use,
submitted by Genentech, Inc. The
proposed indications (uses) for this
product are for: (1) The treatment of
patients with relapsed or refractory,
follicular lymphoma as a single agent;
(2) previously untreated follicular
lymphoma in combination with first
line chemotherapy and, in patients
VerDate Sep<11>2014
18:19 Mar 14, 2017
Jkt 241001
achieving a complete or partial response
to rituximab/hyaluronidase for
subcutaneous injection in combination
with chemotherapy, as single-agent
maintenance therapy; (3) nonprogressing (including stable disease),
follicular lymphoma as a single agent
after first-line cyclophosphamide,
vincristine, and prednisone (CVP)
chemotherapy; (4) the treatment of
patients with previously untreated
diffuse large B-cell lymphoma (DLBCL)
in combination with cyclophosphamide,
doxorubicin, vincristine, prednisolone
(CHOP) or other anthracycline based
chemotherapy regimens; and (5) in
combination with fludarabine and
cyclophosphamide (FC), for the
treatment of patients with previously
untreated and previously treated
chronic lymphocytic leukemia (CLL).
During the afternoon session, the
committee will discuss new drug
application (NDA) 209099, for
binimetinib, submitted by Array
BioPharma Inc. The proposed indication
(use) for this product is for the treatment
of patients with unresectable or
metastatic melanoma, with NRAS Q61
mutation as detected by an FDAapproved test, who have received prior
treatment with checkpoint inhibitor
therapy.
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 March 24, 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
PO 00000
Frm 00037
Fmt 4703
Sfmt 9990
or before March 21, 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 March 22, 2017.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2017–N–1063.
The docket will close on March 28,
2017. Comments received on or before
March 24, 2017, will be provided to the
committee. Comments received after
that date will be taken into
consideration by the Agency.
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
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: March 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05188 Filed 3–14–17; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\15MRN1.SGM
15MRN1
Agencies
[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Notices]
[Pages 13823-13824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05188]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1063]
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) 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 meeting will be held on March 29, 2017, from 8 a.m. to 5
p.m. Submit either electronic or written comments on this document by
March 28, 2017. Late, untimely filed comments will not be considered.
Electronic comments must be submitted on or before March 28, 2017. The
https://www.regulations.gov electronic filing system will accept
comments until midnight Eastern Time at the end of March 28, 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.
ADDRESSES: Sheraton College Park North Hotel, Chesapeake Ballroom, 4095
Powder Mill Road, Beltsville, MD 20705. The hotel's telephone number is
301-937-4422. 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.
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 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-1063 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 DATES), 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
[[Page 13824]]
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: 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: 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: During the morning session of March 29, 2017, the committee
will discuss biologics license application (BLA) 761064, rituximab/
hyaluronidase injection for subcutaneous use, submitted by Genentech,
Inc. The proposed indications (uses) for this product are for: (1) The
treatment of patients with relapsed or refractory, follicular lymphoma
as a single agent; (2) previously untreated follicular lymphoma in
combination with first line chemotherapy and, in patients achieving a
complete or partial response to rituximab/hyaluronidase for
subcutaneous injection in combination with chemotherapy, as single-
agent maintenance therapy; (3) non-progressing (including stable
disease), follicular lymphoma as a single agent after first-line
cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy; (4)
the treatment of patients with previously untreated diffuse large B-
cell lymphoma (DLBCL) in combination with cyclophosphamide,
doxorubicin, vincristine, prednisolone (CHOP) or other anthracycline
based chemotherapy regimens; and (5) in combination with fludarabine
and cyclophosphamide (FC), for the treatment of patients with
previously untreated and previously treated chronic lymphocytic
leukemia (CLL). During the afternoon session, the committee will
discuss new drug application (NDA) 209099, for binimetinib, submitted
by Array BioPharma Inc. The proposed indication (use) for this product
is for the treatment of patients with unresectable or metastatic
melanoma, with NRAS Q61 mutation as detected by an FDA-approved test,
who have received prior treatment with checkpoint inhibitor therapy.
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 March 24, 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
March 21, 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 March 22, 2017.
Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
FDA is establishing a docket for public comment on this meeting.
The docket number is FDA-2017-N-1063. The docket will close on March
28, 2017. Comments received on or before March 24, 2017, will be
provided to the committee. Comments received after that date will be
taken into consideration by the Agency.
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 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: March 10, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05188 Filed 3-14-17; 8:45 am]
BILLING CODE 4164-01-P